Facial mask apparatus with removable filter

ABSTRACT

A face mask for extended wear by a user including a customized, contoured facial mask portion constructed and configured to cover and matingly contact a corresponding contoured surface area of a human face, preferably formed by 3D printing methods and materials. The face mask includes strap attachments and at least one strap for securing the customized, contoured facial mask portion to the face. The face mask includes at least one replaceable air filter for filtering out viral or bacterial pathogens.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is related to and claims priority from the followingU.S. patents and patent applications. This application is acontinuation-in-part of U.S. application Ser. No. 16/410,594, filed May13, 2019, which is a continuation-in-part of U.S. application Ser. No.16/013,560, filed Jun. 20, 2018, which is a continuation of U.S.application Ser. No. 15/710,417, filed Sep. 20, 2017, which is acontinuation-in-part of U.S. application Ser. No. 13/835,059, filed Mar.15, 2013, each of which is incorporated herein by reference in itsentirety.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to a face mask apparatus, and moreparticularly, to a face mask apparatus with a removable filter, andmethods of making the same.

2. Description of the Prior Art

It is also known in the art to provide customizable masks for facialapplication. It is further known in the art to use computer aided designfor custom face mask design and manufacture. It is also known to providethree-dimensional (3D) facial data for use for fabrication of acustom-fit mask for medical procedures.

It is further known to provide masks for preventing or reducing thespread of airborne pathogens, including COVID-19. COVID-19 masks includecloth and soft polymer-based face coverings, in addition to hard polymerface shields.

Examples of relevant prior art reference documents include thefollowing:

U.S. Publication No. 20120305003 for “Rapid Production Of CustomizedMasks” by inventor Mark, filed Oct. 21, 2009 and published Dec. 6, 2012,is directed to a system designed for the rapid preparation ofanatomically customized mask employing data from a patient. The data maytake the form of a multidimensional image of a target area of apatient's face obtained by optical 3 dimensional imaging, or a dot orline scan form laser imaging, pattern laser photography or stereophotography. Also disclosed is a mask that is made of a thin layer, soit is lightweight and closely hugs the targeted region upon which itrests (e.g. the nasal region). The body of the mask is made of a thinlayer, so it is lightweight and closely hugs the targeted region uponwhich it rests (e.g. the nasal region). Methods for producinganatomically customized masks are also described.

U.S. Pat. No. 5,280,305 for “Method and apparatus for forming astylized, three-dimensional object” by inventors Monroe et al., filedOct. 30, 1992 and issued Jan. 18, 1994, is directed to a device thatproduces a three-dimensional object with custom art work from anelectronic signal. More particularly, the preferred implementation is adevice for making masquerade-type masks, and includes a digital camerathat captures a front-on image of an individual's face and converts thecaptured image to an electronic signal that is downloaded into apersonal computer. The computer is utilized to select an image, processthat image to remove background, scale the image to correspond to thedimensions and features of a facial die that will be used to mold themask, and to provide for special effects processing of the selectedimage. An ink jet plotter is then directed to print the processed imageupon thin, flat plastic, which is aligned with the facial features ofthe die and deformed to skin tight conformance with the die by avacuum-forming process. The finished mask bears art work, upon itsconvex exterior, that realistically imitates the face of the individualwhich served as the model for the mask.

U.S. Pat. No. 4,985,116 for “Three dimensional plating or etchingprocess and masks therefor” by inventors Mettler et al., filed Feb. 23,1990 and issued Jan. 15, 1991, is directed to a process for plating oretching metalization patterns on the surface of a three dimensionalsubstrate, wherein a flexible plastic mask is fabricated by firstcoating the surface of a thin plastic sheet with vacuum formable ink.The mask is then molded into the shape of the surface into which thepattern is to be formed. A low power YAG laser is used to remove areasof the ink through which light is to be allowed to pass. This mask maythen be used in either a print and plate process or a print and etchprocess by drawing the mask into intimate contact with the workpiece byapplying a vacuum between the mask and the workpiece. The workpiece maythen be exposed to light through the clear areas of the mask.

U.S. Pat. No. 8,020,276 for “System and method for custom-orienting amedical mask to an oral appliance” by inventor Thornton, filed Nov. 29,2007 and issued Nov. 20, 2011, is directed to a medical mask including abody and an orientation structure. The body includes a first polymer, isconfigured to cover portions of a user's face comprising the user'smouth and at least portions of the user's nose comprising the nostrils,and is further configured to contact the user's face surrounding thecovered portions of the user's face to substantially prevent gas fromescaping between the body and the contacted portions of the user's face.The orientation structure is configured to receive an oral appliancepost to establish and maintain a custom orientation between the medicalmask and the oral appliance post and the orientation structure includesa deformable material which includes a second polymer capable oftransitioning between deformable and non-deformable states.

U.S. Pat. No. 8,254,637 for “Mask fitting system and method” byinventors Abourizk et al., filed Jul. 26, 2007 and issued Aug. 28, 2012,is directed to a system and methods for selecting a mask system for apatient, where certain example embodiments include generating 3Dcontours of patients and selecting mask systems based at least on thosecontours. These contours may be generated by using, for example, acushion of translatable pins, a nasal cannular scanning device, and/or ashadow stereopsis sensor. Certain other example embodiments allow imagesand/or videos to be captured and optionally synchronized. Then, imagesof various mask systems may be overlaid to determine how well a masksystem fits. In still other embodiments, a user can hold a transparencycorresponding to a mask design in front of the patient's face todetermine how well a mask system fits.

U.S. Pat. No. 7,827,038 for “Mask fitting system and method” byinventors Richard et al., filed Jun. 6, 2005 and issued Nov. 2, 2010, isdirected to a mask fitting system for selecting a mask system for apatient includes at least one terminal which receives data unique to apatient. The patient data can be scanned in using a scanner, such as ahandheld or 3-D scanner, or the relevant dimensions of the patient canbe simply input into the terminal. A database is provided to store masksystem data relating to a plurality of potential mask system solutionsfor the patient. A communication channel is provided by which the datareceived by the terminal can be compared with mask system data stored ina mask system database, so as to generate a best-fit mask system result.The best-fit result may include one or more mask system recommendationsfor the patient.

U.S. Publication No. 20060023228 for “Custom fit facial, nasal, andnostril masks” by inventor Geng, filed Jun. 10, 2005 and issued Feb. 2,2006, is directed to a process for fabricating a facial mask to customfit a patient's face for a comfortable fit for facilitating variousmedical procedures including the steps of generating a 3D data set todefine a portion of a patient's face to be fitted with a custom mask,fabricating a patient's mask utilizing a patient's 3D facial data set,and fitting a patient with a custom fit facial mask for facilitating adesired medical procedure.

U.S. Publication No. 20040263863 for “System and method for design andmanufacture of custom face masks” by inventors Rogers et al., filed Jan.27, 2004 and issued Dec. 30, 2004, is directed to methods and systemsfor forming face masks. Embodiments may utilize computer-aided designand computer-aided manufacturing to form custom fitted face masks.System software may be configured to acquire facial topographyinformation, design a mask based on the topography information, and sendmask information to a computerized manufacturing device. The softwaremay communicate with a scanning device for facial topography acquisitionand a milling machine for pattern fabrication. In an embodiment, thescanning device may include a linear scan non-contact laser imager. Inan embodiment, the scanning device may be manually moved with respect toan individual being scanned, thereby eliminating the need for motiveapparatus. In such embodiments, position information may be determinedbased on data from a position sensor coupled to the scanning device.

U.S. Publication No. 20100199992 for “Cushion inside a cushion patientinterface” by inventors Ho et al., filed Apr. 27, 2010 and publishedAug. 12, 2010, is directed to a patient interface device that includes amask shell and a cushion assembly. The cushion assembly includes a sealcushion and a support cushion. The seal cushion contacts a first area ofa patient's face to form a seal therewith. The support cushion defines asecond area over a face of such a patient when the patient interfacedevice is being worn. The second area overlaps at least a portion of thefirst area.

U.S. Publication No. 20100258133 for “Face mask” by inventors Todd etal., filed Nov. 11, 2008 and published Oct. 14, 2010, is directed to amask assembly for delivering gas to a patient that includes a mask bodyand a breathing circuit interface. The mask body includes an opening forreception of the gas and includes a seal structure for sealinglyengaging with the face of the patient and surrounding at least the noseand mouth of the patient. The breathing circuit interface includes afirst portion rotatably connected with the mask body and a secondportion that is constructed and arranged to releasably connect with aconduit for delivering the gas to the patient through the opening.

U.S. Publication No. 20080060648 for “Stability Medical Mask” byinventors Thornton et al., filed Sep. 11, 2007 and published Mar. 13,2008, is directed to a medical mask including a rigid sealing portionconfigured to cover and seal around at least a portion of a user's noseincluding the user's nostrils and a rigid stabilizing frame coupled tothe rigid sealing portion. The rigid stabilizing frame includes agenerally horizontal upper support member configured to bear against theuser's forehead, a generally vertical support member coupled between therigid sealing portion and the upper support member, and lower left andright support members coupled between the rigid sealing portion and theupper support member and configured to bear against the user's cheeks.The rigid stabilizing frame defines two openings configured to allow theuser to see through the medical mask when the medical mask is positionedon the user's face.

WIPO Publication No. WO2013026091 for “Manufactured to shape headgearand masks” by inventors Dunn et al., filed Aug. 21, 2012 and publishedFeb. 28, 2013, is directed to a headgear or headgear segments that aremanufactured to shape thereby producing little or no waste material.Techniques such as knitting, braiding, crocheting, and 3D printing canbe used produce the headgear.

U.S. Pat. No. 5,492,116 for “Respiratory mask with floating sealresponsive to pressurized gas” by inventors Scarberry et al., filed Jun.3, 1994 and issued Feb. 20, 1996, is directed to a respiratory maskadapted to confront the face of a user in a manner to float with respectto the user's face on a cushion of gaseous medium contained within themask for user breathing, the gaseous medium being contained within themask by a flexible seal means carried by the mask and maintained insealing engagement with the user's face while providing essentially nostructural support for the mask with respect to the user's face.

U.S. Publication No. 20180064897 for “Delivery of respiratory therapy”by inventors Kwok et al., filed Nov. 10, 2017 and published Mar. 8,2018, is directed to a patient interface including a sealing arrangementadapted to provide an effective seal with the patient's nose, an inletconduit arrangement adapted to deliver breathable gas to the sealingarrangement, and a cover that substantially encloses the sealingarrangement and/or the inlet conduit arrangement.

U.S. Publication No. 20170173289 for “Methods and systems for providinginterface components for respiratory therapy” by inventors Lucey et al.,filed Nov. 7, 2016 and published Jun. 22, 2017 is directed to systemsand methods that permit generation of a digital scan of a user's facesuch as for obtaining of a patient respiratory mask, or component(s)thereof, based on the digital scan. The method may include: receivingvideo data comprising a plurality of video frames of the user's facetaken from a plurality of angles relative to the user's face, generatinga three-dimensional representation of a surface of the user's face basedon the plurality of video frames, receiving scale estimation dataassociated with the received video data, the scale estimation dataindicative of a relative size of the user's face, and scaling thedigital three-dimensional representation of the user's face based on thescale estimation data. In some aspects, the scale estimation data may bederived from motion information collected by the same device thatcollects the scan of the user's face.

U.S. Publication No. 20150250971 for “Facial mask and method of making”by inventors Bachelder et al., filed Mar. 6, 2015 and published Sep. 10,2015, is directed to masks for various uses and methods for manufacturethereof, including masks for use in continuous positive air pressure(CPAP) therapies. An example includes a mask having a first, relativelysofter material for contact with the face of the user, and a second,relatively harder or more structural material used away from the face ofthe user, with a gradient therebetween. The mask can be produced byadditive manufacturing to avoid a discernible boundary between the firstand second materials.

U.S. Publication No. 20150045926 for “System and method for forming acustom medical mask from a three-dimensional electronic model” byinventor Thornton, filed Oct. 27, 2014 and published Feb. 12, 2015, isdirected to a custom medical mask formed for a particular user from athree-dimensional electronic model includes a body formed from apolymerized photopolymer material. An interior surface of the body isconfigured to seat on the particular user's face and comprises aphysical embodiment of a three-dimensional electronic modelcorresponding to unique facial features of the particular user. Thepublication also describes a method of creating a three-dimensionalelectronic model for use in forming a custom medical mask for aparticular user that includes scanning a portion of the particularuser's face using an electronic scanning device, generating athree-dimensional electronic model of the portion of the particularuser's face based on the scanning, and transmitting thethree-dimensional electronic model of the portion of the particularuser's face for use in forming the custom medical mask for theparticular user from a photopolymer using a stereolithography apparatus.

U.S. Publication No. 20180325206 for “Custom fit mask and strap assemblyand method of producing a custom fit mask and strap assembly” byinventors Siska et al., filed May 9, 2018 and published Nov. 15, 2018,is directed to a method of producing a custom mask and strap assemblyfor an aviator's helmet, including: creating a custom mold usingadditive manufacturing based on at least two physiognomy parameters;forming the custom mask made of an elastomer from the custom mold;assembling the custom mask with a hard shell; and, securing the custommask and the hard shell to the helmet by a strap assembly, the strapassembly including a strap anchor securable to the helmet and a strapslidably connected to the strap anchor. The strap includes a first sideand a second side and further includes a first end securable to a firstportion of the mask with the first side facing the mask and a second endsecurable to a second portion of the mask with the second side facingthe mask.

U.S. Pat. No. 5,372,130 for “Face mask assembly and method having a fanand replaceable filter” by inventors Stern et al., filed Feb. 26, 1992and issued Dec. 13, 1994, is directed to a face mask assembly and methodof use having a housing and a replaceable filter mounted in saidhousing. A fan means draws air into a plenum chamber defined by saidhousing and said filter for this air to pass into a facial breathingarea. An outlet check valve is provided, and a primary filter throughwhich air passes before entering said plenum chamber.

U.S. Patent Publication No. 2020/0206543 for “General-purpose syntheticresin mask using velcro inserting-type filter exchange mode, andinjection molding and manufacturing method therefor” by inventor Lee,filed Mar. 10, 2020 and published Jul. 2, 2020, is directed to a velcroinserting type universal synthetic resin mask with a replaceable filter,an injection molding apparatus therefor, and a manufacturing methodthereof are described. The velcro inserting type universal syntheticresin mask with a replaceable filter can include a mask guide with arim-like shape which supports a filter insertion portion therein and isformed of a synthetic resin by an injection molding process using anupper mold and a lower mold along with the filter insertion portion; anda velcro for attachment of a filter which is placed at a front portionof a velcro entity for attachment of a filter forming portion of theupper mold during the injection molding process for the mask guide andthe filter insertion portion and formed on the mask guide when insertedsuch that the velcro for attachment of a filter is fixed through avelcro entity insertion hole of the upper mold.

U.S. Patent Publication No. 2015/0034098 for “Air filtration mask withopening front cover” by inventor Schumacher, filed Jul. 11, 2014 andpublished Feb. 5, 2015, is directed to an air filtration mask formedfrom individual connectable components namely a base member, a filterholder member, a filter member, and an optional decorative mask covermember. The base member employs studs which allow the filter holdingmember to securely attach to the base member by means of holes inlatches located around the rim of the filter holder member. Areplaceable filter member attaches to the filter holder member snappinginto the studs located on the inside of the filter holder. A fashionmask cover member can be attached to the front of the filter holder toenhance the appearance. A fashion scarf or bandana can be furtherattached to the base of the mask so that the mask assembly can staycompletely hidden while worn.

SUMMARY OF THE INVENTION

The present invention relates to extended wear contoured facial masks.

It is an object of this invention to provide a customized, contouredfacial mask constructed and configured to cover and to contact acorresponding contoured surface area covering a substantial surface areaof a human face.

A further object of this invention is to provide methods of making thecustomized, contoured facial mask using three-dimensional (3D) printingmethods and materials.

Accordingly, a broad embodiment of this invention is directed tocustomized, contoured facial masks with a removable air filter.

In one embodiment, the present invention is directed to a facial mask,including a customized, contoured facial mask portion constructed andconfigured to matingly cover a corresponding contoured surface area of aface of an individual user and match facial contours of the face of theindividual user, wherein the facial mask includes strap attachments andat least one strap for securing the customized, contoured facial maskportion to the face of the individual user during use, wherein thecustomized, contoured facial mask portion includes a contact portion formatingly contacting the face of the individual user during use, whereinthe contact portion is formed based on a three-dimensional (3-D) scan ofthe face of the individual user, and the contact portion is adapted toconform to unique facial features and match the facial contours of theindividual user, wherein the contact portion is configured to notcontact a nose of the individual user during use, wherein the contactportion is configured to not contact a glabella of the individual userduring use, wherein the contact portion is configured to seal aroundeyes of the individual user during use, wherein the contact portion isadapted to substantially contact a forehead of the individual userduring use, wherein the facial mask is configured to cover the glabellaof the individual user during use, wherein the facial mask is configuredto not cover and not contact the eyes of the individual user during use,wherein the at least one strap is sized to extend around the individualuser's head and is for applying a pressure distributed across thecustomized, contoured facial mask portion, and wherein the facial maskincludes at least one replaceable air filter operable to filterbacterial and viral pathogens.

In another embodiment, the present invention is directed to a facialmask, including a customized, contoured facial mask portion constructedand configured to matingly cover a corresponding contoured surface areaof a face of an individual user and match facial contours of the face ofthe individual user, wherein the facial mask includes strap attachmentsand at least one strap for securing the customized, contoured facialmask portion to the face of the individual user during use, wherein thecustomized, contoured facial mask portion includes a contact portion formatingly contacting the face of the individual user during use, whereinthe contact portion is formed based on a three-dimensional (3-D) scan ofthe face of the individual user, and the contact portion is adapted toconform to unique facial features and match the facial contours of theindividual user, wherein the customized, contoured facial mask portionis adapted to extend below a chin of the individual user during use,wherein the contact portion is configured to not contact a chin boss ofthe individual user during use, wherein the contact portion isconfigured to not contact a nose of the individual user during use,wherein the contact portion is configured to not contact a glabella ofthe individual user during use, wherein the facial mask is configured tocover the glabella of the individual user during use, wherein the facialmask is configured to not cover and not contact the eyes of theindividual user during use, wherein the facial mask includes a firstmaterial in contact with the face of the individual user and a secondmaterial to provide structural support to the facial mask, and whereinthe facial mask includes at least one replaceable air filter operable tofilter bacterial and viral pathogens.

In yet another embodiment, the present invention is directed to a facialmask, including a customized, contoured facial mask portion constructedand configured to matingly cover a corresponding contoured surface areaof a face of an individual user and match facial contours of the face ofthe individual user, wherein the facial mask includes strap attachmentsand at least one strap for securing the customized, contoured facialmask portion to the face of the individual user during use, wherein thecustomized, contoured facial mask portion includes a contact portion formatingly contacting the face of the individual user during use, whereinthe contact portion is formed based on a three-dimensional (3-D) scan ofthe face of the individual user, and the contact portion is adapted toconform to unique facial features and match the facial contours of theindividual user, wherein the customized, contoured facial mask portionis adapted to extend below a chin of the individual user during use,wherein the contact portion is configured to not contact a chin boss ofthe individual user during use, wherein the contact portion isconfigured to not contact a nose of the individual user during use,wherein the contact portion is configured to seal around eyes of theindividual user during use, wherein the contact portion is adapted tosubstantially contact a forehead of the individual user during use,wherein the facial mask is configured to cover a glabella of theindividual user during use, wherein the facial mask is configured to notcover and not contact the eyes of the individual user during use,wherein the facial mask includes a first material in contact with theface of the individual user and a second material to provide structuralsupport to the facial mask, and wherein the facial mask includes atleast one replaceable air filter operable to filter bacterial and viralpathogens.

These and other aspects of the present invention will become apparent tothose skilled in the art after a reading of the following description ofthe preferred embodiment when considered with the drawings, as theysupport the claimed invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of a perspective view of one embodiment ofthe invention.

FIG. 2 is a schematic diagram of a perspective view of anotherembodiment of the invention.

FIG. 3 is a schematic diagram of a perspective view of yet anotherembodiment of the invention.

FIG. 4 is a schematic diagram of a perspective view of still anotherembodiment of the invention.

FIG. 5 illustrates a perspective view of one embodiment of a facial maskhaving a rounded edge.

FIG. 6 is a schematic diagram of one embodiment of a facial mask havingat least one zone with a graduated thickness.

FIG. 7 is a schematic diagram of another embodiment of a facial maskhaving at least one zone with a graduated thickness.

FIG. 8 is a schematic diagram of yet another embodiment of a facial maskhaving at least one zone with a graduated thickness.

FIG. 9 is a schematic diagram of a perspective view of one embodiment ofthe invention having two zones of graduated pressure.

FIG. 10 is a schematic diagram of a perspective view of anotherembodiment of the invention having two zones of graduated pressure.

FIG. 11 is a schematic diagram of a top view of an embodiment of theinvention.

FIG. 12 is a schematic diagram of a side view of an embodiment of theinvention.

FIG. 13 is a schematic diagram of a side view of another embodiment ofthe invention.

FIG. 14 is a schematic diagram of a side view of yet another embodimentof the invention.

FIG. 15 is a schematic diagram of a side view of an embodiment of theinvention shown in FIG. 9.

FIG. 16 illustrates ventilation holes according to one embodiment of theinvention.

FIG. 17 illustrates ventilation holes according to another embodiment ofthe invention.

FIG. 18 is a schematic diagram of a top view of an embodiment of theinvention with ventilation holes.

FIG. 19 is a schematic diagram of a side view of an embodiment of theinvention with ventilation holes.

FIG. 20 illustrates a half-ellipsoid with axes a, b, and c, and a heighth of an ellipsoid cap.

FIG. 21 shows an angled perspective view of the half-ellipsoid with 20%of the surface area, 50% of the surface area, and 80% of the surfacearea of the half-ellipsoid labeled.

FIG. 22 shows a side perspective view of the half-ellipsoid with 20% ofthe surface area, 50% of the surface area, 80% of the surface area, and100% of the surface area of the half-ellipsoid labeled.

FIG. 23A illustrates one embodiment of a facial mask including face maskmagnets for attaching eyeglasses.

FIG. 23B illustrates one embodiment of eyeglasses including eyeglassesmagnets.

FIG. 23C illustrates the eyeglasses of FIG. 23B magnetically attached tothe face mask of FIG. 23A.

FIG. 24 illustrates one embodiment of a facial mask with a clip forattaching eyeglasses.

FIG. 25 illustrates one embodiment of a face mask with a removable airfilter.

FIG. 26 illustrates another embodiment of a face mask with a removableair filter.

FIG. 27 illustrates yet another embodiment of a face mask with aremovable air filter.

FIG. 28 illustrates still another embodiment of a face mask with aremovable air filter.

FIG. 29 illustrates one embodiment of a face mask with a removable airfilter and a temperature sensor.

FIG. 30 illustrates one embodiment of a face mask with a removable airfilter and a temperature sensor.

FIG. 31 illustrates one embodiment of an attachment mechanism for aremovable filter.

FIG. 32 illustrates one embodiment of a removable air filter for a facemask.

DETAILED DESCRIPTION

The present invention is generally directed to a face mask apparatus,and more particularly, to a face mask apparatus with a removable filter,and methods of making the same.

In one embodiment, the present invention is directed to a facial mask,including a customized, contoured facial mask portion constructed andconfigured to matingly cover a corresponding contoured surface area of aface of an individual user and match facial contours of the face of theindividual user, wherein the facial mask includes strap attachments andat least one strap for securing the customized, contoured facial maskportion to the face of the individual user during use, wherein thecustomized, contoured facial mask portion includes a contact portion formatingly contacting the face of the individual user during use, whereinthe contact portion is formed based on a three-dimensional (3-D) scan ofthe face of the individual user, and the contact portion is adapted toconform to unique facial features and match the facial contours of theindividual user, wherein the contact portion is configured to notcontact a nose of the individual user during use, wherein the contactportion is configured to not contact a glabella of the individual userduring use, wherein the contact portion is configured to seal aroundeyes of the individual user during use, wherein the contact portion isadapted to substantially contact a forehead of the individual userduring use, wherein the facial mask is configured to cover the glabellaof the individual user during use, wherein the facial mask is configuredto not cover and not contact the eyes of the individual user during use,wherein the at least one strap is sized to extend around the individualuser's head and is for applying a pressure distributed across thecustomized, contoured facial mask portion, and wherein the facial maskincludes at least one replaceable air filter operable to filterbacterial and viral pathogens.

In another embodiment, the present invention is directed to a facialmask, including a customized, contoured facial mask portion constructedand configured to matingly cover a corresponding contoured surface areaof a face of an individual user and match facial contours of the face ofthe individual user, wherein the facial mask includes strap attachmentsand at least one strap for securing the customized, contoured facialmask portion to the face of the individual user during use, wherein thecustomized, contoured facial mask portion includes a contact portion formatingly contacting the face of the individual user during use, whereinthe contact portion is formed based on a three-dimensional (3-D) scan ofthe face of the individual user, and the contact portion is adapted toconform to unique facial features and match the facial contours of theindividual user, wherein the customized, contoured facial mask portionis adapted to extend below a chin of the individual user during use,wherein the contact portion is configured to not contact a chin boss ofthe individual user during use, wherein the contact portion isconfigured to not contact a nose of the individual user during use,wherein the contact portion is configured to not contact a glabella ofthe individual user during use, wherein the facial mask is configured tocover the glabella of the individual user during use, wherein the facialmask is configured to not cover and not contact the eyes of theindividual user during use, wherein the facial mask includes a firstmaterial in contact with the face of the individual user and a secondmaterial to provide structural support to the facial mask, and whereinthe facial mask includes at least one replaceable air filter operable tofilter bacterial and viral pathogens.

In yet another embodiment, the present invention is directed to a facialmask, including a customized, contoured facial mask portion constructedand configured to matingly cover a corresponding contoured surface areaof a face of an individual user and match facial contours of the face ofthe individual user, wherein the facial mask includes strap attachmentsand at least one strap for securing the customized, contoured facialmask portion to the face of the individual user during use, wherein thecustomized, contoured facial mask portion includes a contact portion formatingly contacting the face of the individual user during use, whereinthe contact portion is formed based on a three-dimensional (3-D) scan ofthe face of the individual user, and the contact portion is adapted toconform to unique facial features and match the facial contours of theindividual user, wherein the customized, contoured facial mask portionis adapted to extend below a chin of the individual user during use,wherein the contact portion is configured to not contact a chin boss ofthe individual user during use, wherein the contact portion isconfigured to not contact a nose of the individual user during use,wherein the contact portion is configured to seal around eyes of theindividual user during use, wherein the contact portion is adapted tosubstantially contact a forehead of the individual user during use,wherein the facial mask is configured to cover a glabella of theindividual user during use, wherein the facial mask is configured to notcover and not contact the eyes of the individual user during use,wherein the facial mask includes a first material in contact with theface of the individual user and a second material to provide structuralsupport to the facial mask, and wherein the facial mask includes atleast one replaceable air filter operable to filter bacterial and viralpathogens.

In 2020 and 2021, COVID-19 became a daily worry in people's lives. Maskswere and, in some cases, still are required when carrying out a varietyof basic tasks, including going to the store, going to work, and pickingup kids from school. However, masks currently available on the marketcause irritation for many people, whether because of the material out ofwhich the mask is made, or because the mask is required to contactsensitive areas of the face for long periods of time. Furthermore, manyof the masks currently on the market fail to adequately protect a wearerfrom catching the virus, either due to a poor quality of material, ordue to leaks in the coverage of the mask on the face.

Masks often come in standardized sizes (e.g., small, medium, large).Additionally, there are different masks for adults and children.However, the masks are typically not customized and create impressionson the face, and/or cause rashes on areas of the face of the user duringand/or after use. As the mask must often be worn for much of the day,these impressions and rashes on the face of the user are frequentlyrecited as issues of extreme discomfort. Further, many users have to tryout multiple masks in order to find one that is comfortable and fitsproperly, which causes frustration and additional costs. These issuesare just a few of many factors that decrease mask compliance during apandemic, which also include contact dermatitis caused by prolongedcontact with the mask and/or allergic reaction to the mask, inability tocommunicate via speech or facial expressions, lack of customizability ofmasks, fogging of eyeglasses during use of the mask, improper sizing ofthe mask, and/or physical discomfort with the mask.

It is difficult to find a mask with a good fit because facial dimensionsand contours are unique to each person. In a 2014 study conducted bySheehan and Nachman published in Nature Communications, the researchersused a database of body measurements compiled from male and femalemilitary personnel in 1988 to evaluate the variability in human facialfeatures based on sixteen different facial measurements. The researchersconcluded that each individual facial trait is independent of otherfacial traits, unlike traits of other parts of the body. For example,while the length and width of an individual's hand are correlated, suchthat a person with a long hand is generally also expected to have a widehand, the length and width of the nose are not correlated. Further, thelargest amount of variability with facial traits are within the triangleof the eyes, mouth, and nose. Because the nose and the mouth must becovered in order for a COVID-19 mask to be effective, this highvariability area is an area of importance for proper mask fit.

Because their masks often does not fit properly, users frequentlytighten the straps of the mask too much in order to create a seal,causing pain and discomfort. On the other hand, many users loosen themask too much such that no seal forms at all, allowing pathogens to passeasily into or out of the user's mouth or nose. Further, the mask oftencauses creases, lines, rashes or other undesired cosmetic changes in theuser's face due to extended use of the mask. Most prior art masks areconfigured for both perimeter contact of the mask with the face (e.g.,around the entire face or around the nose and mouth) and contact of theinterior mask with most areas of the face, as cloth and soft polymerseasily stick to the face. Therefore, while creases often appear at theperimeter of the mask, rashes and other sensitized areas appear also inthe interior region of the mask. Furthermore, many masks, especiallysurgical-style masks, include a stiffer wire portion designed to conformaround the bridge of the nose. Long-term pressure of the stiffer wireagainst the nose frequently leads to discomfort for users. Further,other masks have one or more straps around the ears of the user, whichleave creases and/or rashes behind the ear.

What is needed is a facial mask to protect against airborne pathogensall day that is comfortable, provides a custom fit for the user, anddoes not cause lines, wrinkles, rashes and other undesired cosmeticchanges in the user's face. There is a long-felt unmet need for a facialmask that prevents undesired cosmetic changes in the user's face due toextended wear of the mask, provides for increased comfort by contactinga large surface area of the face while not contacting the glabella, thephiltrum, the nose or the chin boss of the user, requires only one strapto hold the mask to the user's face, and does not cover and does notcontact the eyes of the individual user.

None of the prior art discloses a facial mask that matingly contacts atleast 50% of the surface area of the face and matches the facialcontours of the individual user, does not cover and does not contact theeyes during use, does not cause undesired cosmetic changes in the user'sface, and does not contact the glabella, the nose, the nasolabial folds,the philtrum, and the chin boss of the user. Advantageously, the facialmask of the present invention is able to be secured to the user's facewith a single strap due to the large surface area of the face (i.e., atleast 50% of the surface area) in mating contact with the facial mask.Preferably, mating contact or “matingly” as used in this applicationmeans that two components are formed of mutually complementing shapesthat physically connect. Examples of mating connections includeelectrical connectors, jigsaw puzzles, and a bolted joint. One of themost common examples of a mating connection is a bolt, which hasexternal threads, and a nut, which has internal threads. In thisexample, the bolt acts as a “male” component, while the nut acts as a“female” component. Mating components maintain their entire physicalintegrity when in contact with each other. Neither component becomesdeformed when in contact with the other.

Referring now to the drawings in general, the illustrations are for thepurpose of describing a preferred embodiment of the invention and arenot intended to limit the invention thereto.

The present invention provides a three-dimensional (3D) printed customface mask component of a sleep apnea treatment device, which addressesthe need for customizable masks connected to the machine. The presentinvention utilizes 3D printing technology to create customizable masksfor sleep apnea patients.

The present invention provides a customized sleep apnea mask formedutilizing 3D printing technologies that conforms to the unique facialfeatures of an individual user. The mask embodiments of the presentinvention are customizable for each user to provide matching contours ofthe human face for increased comfort when the mask is worn.

Advantageously, in one embodiment of the present invention, the facialmask provided in the present invention is able to be safely washed in adishwasher or using another common household appliance.

In one embodiment of the present invention, a 3D model of theanatomically customized mask is created using multidimensional data ofan individual's face. The multidimensional data of the individual's faceis operable to be acquired through the use of 3D scanners, multipleimage or video cameras and digital reconstruction software, dot or linescans from laser imaging, pattern laser photography, stereo photography,or any number of 3D modeling technologies. In one embodiment, themultidimensional data of the individual's face is acquired while theindividual is lying down. Once digitization of the face's 3D surfaceoccurs, an operator is operable to further customize the mask to provideenhanced functionality and aesthetics. For example, and not by way oflimitation, the operator is operable to use a computer aided design(CAD) or modeling software to define the boundaries of the mask, createmodifications such as strap attachment slit or airway passage, or allowfor modular connections such as for a breathing tube.

In another embodiment, the multidimensional data of the individual'sface is obtained using a smartphone or a tablet. The multidimensionaldata of the individual's face is acquired through multiple images and/orvideo taken with the smartphone or the tablet. In one embodiment, thesmartphone or the tablet utilizes an accelerometer or other sensors toensure that sufficient data is acquired. In another embodiment, thesmartphone or the tablet has a mobile application that is operable totransmit the multidimensional data of the individual's face to theoperator. The mobile application is also operable to allow theindividual to request modifications and features to customize the facialmask.

Since 3D printing in additive printing embodiments involves printing inlayers, any digitized model must be mathematically translated, usuallyby the printer software, into cross-sections or “slices” of the desiredprint-out. Any intermediate or finalized 3D digital model (e.g., a STL,VRML, or AMF file) is operable to be read by the 3D printer for creatingthe cross-sections or “slices.” Additionally, the model is analyzed bythe printer software in order to determine the most structurallyefficient location to print extraneous supports to aid in the printingprocess. These supports are operable to be removed through chemical ormanual removal techniques following printing.

In another embodiment, subtractive manufacturing is used in order toremove material from a starting material or block. In this case,standard mathematical operations are performed by the 3D printer todetermine the appropriate angle, strength, and depth with which toremove material from the starting material or block. This process iscompleted on a subtractive 3D printer (e.g., a CNC machine). In apreferred embodiment, the subtractive 3D printer is operable to cutaround at least three axes. Advantageously, this minimizes the number oftimes the starting material or block must be turned during the printingprocess. In one embodiment, a combination of additive and subtractiveprinting methods is used to manufacture the face mask.

In yet another embodiment, more advanced methods of 3D are used, such aslaser-based stereolithography (SLA), digital light processing (DLP), orother resin-based printing methods, such as continuous liquid interfaceproduction (CLIP). The resin-based methods provide the benefit of morecustomizable, faster printing, while allowing for variability inmaterial choice.

Furthermore, the present invention allows for 3D modeling data to bestored in a database for future use. In one embodiment, such a database,housed in a non-transitory medium such as the memory of a computer,contains modeling data for individual face contours, modifications tothese contours, templates for enhanced functionality or aesthetics, or3D models of objects to be incorporated into or on to a facial mask. Inone embodiment, the database of modeling data is used to reproducepreviously printed 3D masks and/or is be used to adapt such data to afuture use, including inventory management, record-keeping, or branding.In one embodiment, the database is accessible through a web interface,providing access to operators, customers, or third parties, with grantedaccess to the database capable of being limited. In one embodiment, thedatabase is accessible through a mobile application on a smartphone.

Importantly, to ensure customized fit of the face mask, the contactportion of the customized, contoured facial mask is constructed andconfigured to cover and to matingly contact a corresponding contouredsurface area of a human face, is unitarily and integrally formed by 3Dprinting, and is formed of a synthetic material or plastic. Preferably,a flexible layer is provided on the surface that contacts the face ofthe user, i.e., that contacts and “mates” with the contours of theuser's face, for additional comfort increase. In one embodiment, theflexible layer is a soft plastic layer, a silicone layer, or a rubberlayer. So then both the coverage of the mask over the face of the userand the soft underside layer each separately and in combination providemaximum pressure distribution over the face surface of the user. Thus,the face mask is operable to be formed of a stratified, multilayerstructure, wherein the underside layer that contacts the user's face isa softer material than the outer layer, although the layers are operableto be formed integrally together or bonded together. A stratified,multilayer mask refers to a mask formed or deposited in individuallayers, wherein one layer is over or under at least one other layer(i.e., like stratified rock formations in geology). In a preferredembodiment, the underside layer is a flexible layer and the outer layeris a rigid layer. The rigid outer layer provides structural support forthe face mask, while the flexible underside layer provides comfort tothe user.

U.S. Publication No. 20150250971 describes multi-layered facial masksand is hereby incorporated by reference in its entirety. In oneembodiment, the facial mask includes a gradient between a first layerand a second layer. The gradient is in a horizontal direction and/or avertical direction. In another embodiment, the facial mask includes morethan one gradient. In yet another embodiment, the first layer is incontact with the face and the second layer provides structural support.

U.S. Pat. Nos. 5,869,170, 7,565,633, 7,845,352, 7,963,284, 8,147,910,8,175,734, 8,874,251, and 9,345,849, U.S. Publication Nos. 20120224755,20150042762, 20150045926, 20170173289, 20170173892, 20180325206, and20180369529, and European Patents 2486547 and 2482248 are herebyincorporated by reference in their entirety. These documents describedetails of 3D printing, materials used for 3D printing, and customizablemasks made of plastic or gel materials including but not limited toplastic, living cells, leather, nylon, metal, and thermoplastics. In oneembodiment, the facial mask is formed of at least one composition thatis curable using ultraviolet (UV) light (e.g., TangoPlus FLX930,VeroClear RGD810).

In one embodiment, the face mask includes at least one reinforcingmaterial. The at least one reinforcing material is a carbon fiber, anaramid (e.g., Kevlar®), a para-aramid (e.g., Twaron®), anultra-high-molecular-weight polyethylene (e.g., Spectra Shield), poly(p-phenylene-2,6-benzobisoxazole) (e.g., Zylon), silk, and/or a glassfiber.

In another embodiment, the face mask incorporates at least one ballisticresistant material. The at least one ballistic resistant material is anaramid, a para-aramid, a polypropylene, a polyethylene, poly(p-phenylene-2,6-benzobisoxazole), a liquid crystal polymer (e.g.,Vectran®), and/or a polyester.

In yet another embodiment, the face mask incorporates at least onefireproof or fire-resistant material. The at least one fireproof orfire-resistant material is thermoplastic polyurethane, a polycarbonate,an aramid, a para-aramid, a meta-aramid (e.g., Nomex®), apolybenzimidazole (e.g., Celazole®), a polyimide (e.g., P84®), amelamine derivative (e.g., Basofil®), a phenol derivative (e.g.,Kynol®), a polyetherimide, a polyphenylene sulfide fiber (e.g.,TORCON™), a liquid crystal polymer (e.g., Vectran®), and/or a glassfiber.

The face mask incorporates at least one waterproof or water-resistantmaterial in another embodiment. The at least one waterproof orwater-resistant material is silicone, rubber, a synthetic rubber (e.g.,Neoprene®), and/or a plastic (e.g., polycarbonate, polyvinyl chloride,polypropylene, polyethylene).

U.S. Publication No. 20120305003 for “Rapid Production of CustomizedMasks” by inventor Mark, filed Oct. 21, 2009 and published Dec. 6, 2012,is hereby incorporated by reference in its entirety. This applicationdescribes a system designed for the rapid preparation of anatomicallycustomized mask employing data from a patient. The data is operable totake the form of a multidimensional image of a target area of apatient's face obtained by optical 3-dimensional imaging, or a dot orline scan form laser imaging, pattern laser photography or stereophotography. Also disclosed is a mask that is made of a thin layer, soit is lightweight and closely hugs the targeted region upon which itrests (e.g., the nasal region).

FIG. 1 is a schematic diagram of a perspective view of one embodiment ofthe invention. The contact area is depicted in FIG. 1 by the shadedregion. In a preferred embodiment, the contact area of the facial mask10 includes the forehead 12 and the cheeks 14. The forehead 12 is theskin under the hairline and above the eyebrows and ears. Preferably, themask is configured to cover and matingly contact about 90% of theforehead during use. In other embodiments, the mask is configured tocover and matingly contact about 100% of the forehead during use, about95% of the forehead during use, about 85% of the forehead during use,about 80% of the forehead during use, about 75% of the forehead duringuse, or about 70% of the forehead during use. The cheeks 14 are oneither side of the face below the eye and above the jaw. The cheeks 14are by surface area the largest subunit of the face. Preferably, themask is configured to cover and matingly contact about 90% of the cheeksduring use. In other embodiments, the mask is configured to cover andmatingly contact about 100% of the cheeks during use, about 80% of thecheeks during use, about 70% of the cheeks during use, about 60% of thecheeks during use, about 55% of the cheeks during use, or about 50% ofthe cheeks during use. In one embodiment, the contact area includes thebrow ridges (supraorbital ridges) 40.

In a preferred embodiment, the facial mask 10 does not cover and doesnot contact the eyes of the user. As shown in FIG. 1, the facial mask 10preferably includes two openings 16 for the user's eyes when the facialmask 10 is on the face of the user. The mask is thus preferably inmating contact with the skin which surrounds the eyes of the user. Fullface masks often fog up or become dirty and block the user's vision.Additionally, full face masks lead to dry eyes and other eye issues forpatients. The present invention advantageously does not cover and doesnot contact the eyes, which provides comfort to the user and preventsthe eyes from drying out. Further, air leakage from nasal masks alsocauses the eyes of the user to dry out in some instances. This airleakage is often caused by a mask with a poor fit. Advantageously, thepresent invention provides the user with a custom-fit facial mask thatmates with the contours of the user's face, providing a good fit andpreventing air leakage that causes the eyes to dry out. There is along-felt, unmet need in the art for a sleep apnea mask which isoperable to minimize or eliminate cosmetic changes typically caused byextended wear of the mask while simultaneously providing the benefit ofpreventing air leakage that causes the user's eyes to dry out.

The facial mask preferably does not contact the glabella 18, the root ofthe nose 20, the nose 22, the nostrils 24, the philtrum 28, and the chinboss 30 of the user. These areas of the face are more sensitive thanother areas of the face and often cause discomfort to the user ifcontacted by the mask. In another embodiment, the facial mask does notcontact the nasolabial folds (i.e., “smile lines” or “laugh lines”) 26.Some of these areas (e.g., the glabella 18, the nasolabial folds 26, andthe philtrum 28) are prone to wrinkles. Advantageously, not contactingthe face in these areas helps to prevent lines, creases, or otherundesired cosmetic changes in the user's face with continued of thefacial mask.

The present invention differs from the prior art, including U.S.Publication Nos. 20120305003 and 20100258133, in that it is designed tominimize the cosmetic changes to the face of the user upon continual useof the mask. The present invention does this by providing a much largercontact area than the prior art, including the large surfaces areas ofthe face, such as the forehead 12 and the cheeks 14. The term “face” isunderstood by one of ordinary skill in the art. By way of illustrationand not limitation, the term “face” refers to the front portion of thehead, defined vertically from the top of the forehead to the base of thechin and horizontally from the start of each ear. The face thusincludes, inter alia, the forehead, the eyes, the nose, the mouth, thecheeks, the jaw, the glabella, the superciliary arches, the philtrum,the superior palpebral sulcus, the inferior palpebral sulcus, thepalpebromalar sulcus, nasolabial folds, mentolabial sulcus, and anyother features that are located vertically between the top of theforehead and the base of the chin and horizontally between the start ofeach ear. In a preferred embodiment, the facial mask covers and matinglycontacts at least 80% of the surface area of the face of the user. Inanother embodiment, the facial mask covers and matingly contacts atleast 50% of the surface area of the face of the user. Alternatively,the facial mask covers and matingly contacts at least 60% of the surfacearea of the face or at least 70% of the surface area of the face of theuser. In further embodiments, the facial mask covers and matinglycontacts at least 55% of the surface area of the face of the user, atleast 65% of the surface area of the face of the user, and at least 75%of the surface area of the face of the user.

By extending the mask onto these surfaces, the present invention alsoallows for the mask to be constructed so that it does not touch the moresensitive parts of the user's face, including the nose 22 and the chin,especially the chin boss 30. The mask is designed and constructed to nottouch the chin boss 30 such that the user is able to move the chin whilethe mask is on. This mobility is found to reduce the irritation ofwearing a mask.

Some masks of the prior art rely on a flexible peripheral seal aroundthe edges of the mask to conform to the unique features of the user'sface. In order to seal against the face of the user, the flexibleperipheral seal becomes deformed due to the force from the face againstthe peripheral seal. Additionally, or alternatively, the face of theuser becomes deformed during wear of the mask due to the force from theperipheral seal against the face. Pressure is defined as force per unitarea. The force of the mask caused by the straps holding the mask to theface of the user is distributed only across the perimeter contactportion, resulting in a high pressure against the face. This limitedcontact footprint of the flexible peripheral seal around the edges of amask causes creases, lines, or other undesired cosmetic changes in theuser's face upon continual use of the mask.

In contrast, the facial mask of the present invention does not rely onperimeter contact to seal against face. In fact, the force applied fromthe mask to the face or the force applied from the face to the maskaround the edge or perimeter of the mask during use is less than orequal to the average of the entirety of the force applied from the maskto the face or the force applied from the face to the mask during use.The force applied from the mask to the face or the force applied fromthe face to the mask around the edge or perimeter of the mask is alsoless than or equal to the force applied from the mask to the face or theforce applied from the face to the mask at any specific point or groupof points of face/mask contact during use. This results in asubstantially even pressure distribution across the contact area.Additionally, unlike much of the prior art, the mask of the presentinvention does not include a separate peripheral portion to seal aroundthe edge of the mask/face interface because the mask of the presentinvention does not merely seal around the edge of the mask/faceinterface. Advantageously, the facial mask of the present inventionmatingly contacts at least 50% of the surface area of the face, whichprovides a larger surface area to sealingly contact the face. The maskconfiguration also provides for reduced pressure points and/or nopressure points on higher contour areas of the face (e.g., the nose,between the nose and the upper lip, the cheekbones, the jawline, thechin), and therefore provides for increased comfort to the user. For thehigher contour areas of the face in contact with the mask (e.g., thecheekbones, the jawline), the pressure points are reduced due to theforce of the mask on the face being distributed over a large surfacearea (e.g., at least 50% of the surface area of the face). Further,because the facial mask matingly contacts the face, neither the face northe mask become deformed during wear of the mask, which preventscreases, lines, or other undesired cosmetic changes in the user's face.

Additionally, the facial mask matingly contacting the face allows forgreater stability of the mask during the continuous use while sleeping.Users often move while sleeping, which sometimes leads to leaks and apoor fit on the face. Advantageously, the facial mask of the presentinvention matingly contacts the face of the user and matches the facialcontours of the individual user. This prevents the facial mask fromshifting on the user's face while sleeping.

The facial mask preferably includes strap attachments and at least onestrap 34 for securing the mask portion to the face. The at least onestrap 34 is attached to the facial mask via strap attachment points 32.In a preferred embodiment, the strap attachment points 32 are positionedon opposite sides of the facial mask. In one embodiment, the strapattachment points 32 are loop holes. In one embodiment, the strapattachments consist of only two strap attachment points 32. The at leastone strap 34 is sized to extend around the user's head. The at least onestrap 34 is sized to not contact the ears of the individual user. In apreferred embodiment, the at least one strap 34 is sized to not contactthe cheeks of the individual user.

In a preferred embodiment, the at least one strap 34 is a single axialstrap. Advantageously, a single strap is operable to be used with thepresent invention due to the substantial contact of the surface area ofthe face, including the forehead 12 and the cheeks 14 of the user. Incontrast, prior art masks that contact the forehead of the user eitherrequire more than one strap or include the strap in a disadvantageouslocation (e.g., across the ears, the forehead, or the cheeks) thatirritate the user. Including more than one strap is disadvantageousbecause it requires the user to fasten and unfasten at least two strapswhen putting on or removing the mask, as well as requiring contactbetween the straps and the user's head or face in multiple locations.

The at least one strap 34 is for applying a pressure distributed acrossthe customized, contoured facial mask portion, wherein the pressure isdistributed substantially uniformly across the contact portion of thecustomized, contoured facial mask portion. Substantially uniformlydistributed pressure means that the pressure is distributed evenly(i.e., pressure exerted on the face by the mask is equal at every pointof contact between the mask and the face), or alternatively, pressure isdistributed across the mask such that pressure from the mask to the faceat any point of contact between the mask and the face differs by onlybetween about 0-10%, and more preferably between about 0-5%, frompressure from the mask to the face at any other point of contact betweenthe mask and the face. Advantageously, the substantial mating contact ofthe face of the user by the mask, preferably at least 50% of the surfacearea, more preferably at least about 80% of the surface area, providesfor reduced pressure points on higher contour areas of the face, andtherefore provides increased comfort to the user.

In a preferred embodiment, the at least one strap 34 is adjustable toaccommodate different head diameters. The at least one strap 34 isoperable to be formed of an elastic or inelastic material. In oneembodiment, the at least one strap 34 is formed of rubber, silicone, ora foam. In another embodiment, the at least one strap 34 is covered withneoprene. In one embodiment, the at least one strap 34 is adjustableusing at least one toggle, hook-and-loop tape, at least one snap, or atleast one buckle (e.g., cam buckle, side release buckle). In yet anotherembodiment, a length and/or a width of the at least one strap 34 isdetermined based on a 3D scan of the user's head. The at least one strap34 is adjustable or manufactured to a predetermined length and/or apredetermined width, which ensures proper fit of the sleep apnea maskwhen used in conjunction with the customized, contoured facial maskportion.

For increased oxygen intake and to facilitate breathing of the user toaddress issues of sleep apnea, the mask of the present invention furtherincludes an airway passage 36 positioned in the nose region of the mask,and further including a breathing tube 38 connected to the mask at theairway passage 36, which extends outwardly from a nasal area of thecontoured facial mask face surface portion. In one embodiment, theairway passage 36 and the breathing tube connector is molded into thefacial mask. In another embodiment, the breathing tube 38 is removablyattachable to the mask (i.e., it is connectable and disconnectable) by aconnection region 48 that is matingly connectable. By way of example andnot limitation, the connection region 48 includes a threaded zone forrotational connection of the breathing tube 38 with the airway passage.

FIG. 2 is a schematic diagram of a perspective view of anotherembodiment of the invention. In one embodiment, the contact areaincludes the jaw region 42. The facial mask 10 of FIG. 2 contacts alarger surface area of the face than the facial mask of FIG. 1.Specifically, the facial mask 10 of FIG. 2 a larger portion of thecheeks 14, a larger area under the mouth, and a portion of the j awregion 42.

FIG. 3 is a schematic diagram of a perspective view of yet anotherembodiment of the invention. The facial mask 10 of FIG. 3 contacts alarger surface area of the face than the facial mask of FIG. 2.Specifically, the facial mask 10 of FIG. 3 contacts a larger portion ofthe forehead 12 (i.e., is closer to the hairline), a larger portion ofthe cheeks 14, and a larger portion of the j aw region 42.

FIG. 4 is a schematic diagram of a perspective view of still anotherembodiment of the invention. In one embodiment, the facial mask connectswith the strap at a position even with or behind the ear (i.e., evenwith or behind the tragus). In the embodiment shown in FIG. 4, thefacial mask connects with the strap at a position above and behind theear. The strap preferably connects to the strap attachment points on themask above the ear, which positions the strap at an angle between about45 degrees and about 75 degrees from a horizontal line that runs tangentto the top of the ear. The strap extends around the back of the user'shead during use. This configuration of the strap helps ensure that thefacial mask maintains mating contact with the face of the user duringuse. Advantageously, this configuration of the strap allows for agreater surface area of the face to be in mating contact with the facialmask.

The facial mask preferably has no sharp edges. Additionally, the facialmask has a uniform texture for the underside layer. Advantageously, thelack of sharp edges and the uniform texture aid in the prevention oflines, creases, and other cosmetic changes in the face.

In one embodiment, edges of the facial mask (e.g., around the perimeterof the mask, around the eyes) have a rounded edge. FIG. 5 illustrates aperspective view of one embodiment of a facial mask having a roundededge. The facial mask 10 is shown in mating contact with the facialsurface 46 of the individual user.

In one embodiment, the facial mask has at least one zone with agraduated thickness. FIG. 6 is a schematic diagram of one embodiment ofa facial mask having at least one zone with a graduated thickness. In apreferred embodiment, the facial mask 10 has a thickness t between about0.0625 inches and about 0.1875 inches. In another embodiment, the facialmask 10 has a thickness t between about 0.0625 inches and about 0.25inches. In one embodiment, the thickness t is graduated from 0% t to100% t over a distance d. In a preferred embodiment, the distance d isless than or equal to about 1 inch. In another embodiment, the distanced is less than or equal to about 0.75 inch, less than or equal to about0.5 inch, less than or equal to about 0.25 inch, less than or equal toabout 0.125 inch, or less than or equal to about 0.0625 inch. In theexample shown in FIG. 6, the slope of the facial mask 10 in the zone ofgraduated thickness is substantially linear.

Alternatively, the slope of the facial mask 10 in the zone of graduatedthickness is non-linear, as shown in FIG. 7. Further, the distance d isslightly larger in the example shown in FIG. 7 than in the example shownin FIG. 6.

In another embodiment, the thickness t is graduated from an initialthickness t1 to the thickness t over a distance d. In the example shownin FIG. 8, the slope of the facial mask 10 in the zone of graduatedthickness is substantially linear. In one embodiment, the initialthickness t1 is equal to about 10%, about 20%, about 25%, about 30%,about 40%, about 50%, about 60%, about 70%, about 75%, about 80%, orabout 90% of the thickness. Further, the edges are not rounded in theexample shown in FIG. 8.

As previously described, pressure is distributed across the mask suchthat pressure from the mask to the face at any point of contact betweenthe mask and the face differs by only between about 0-10%, and morepreferably between about 0-5%, from pressure from the mask to the faceat any other point of contact between the mask and the face. In oneembodiment, the facial mask has at least one zone of graduated pressure.In a preferred embodiment, the at least one zone of graduated pressureis located at an edge of a contact region (e.g., around the eyes, aroundthe periphery of the mask, around the nasal area). In anotherembodiment, the at least one zone of graduated pressure is located at ahigh contour area of the face (e.g., the cheekbones, the supraorbitalridges, the jawline). Advantageously, this embodiment decreases thepressure on the high contour area of the face, which increases thecomfort to the user.

FIG. 9 is a schematic diagram of a perspective view of one embodiment ofthe invention having two zones of graduated pressure. In one embodiment,zones 52 and 54 are graduated pressure zones each having a pressureequal to less than 100% of the pressure in zone 50. In one example, zone52 has a pressure equal to about 97.5% of the pressure in zone 50 andzone 54 has a pressure equal to about 95% of the pressure in zone 50. Inanother example, zone 52 has a pressure equal to about 95% of thepressure in zone 50 and zone 54 has a pressure equal to about 90% of thepressure in zone 50. Advantageously, the graduated pressure zonedistributes the load to minimize the pressure from the edge of the maskcontacting the face of the user during use, as edge contact from themask to the face of the user sometimes creates lines, wrinkles, or otherundesired cosmetic changes.

FIG. 10 is a schematic diagram of a perspective view of anotherembodiment of the invention having two zones of graduated pressure. Inone embodiment, zones 56 and 58 are graduated pressure zones each havinga pressure equal to less than 100% of the pressure in zone 50. In thisexample, zone 58 is located around each eye and zone 56 is locatedaround the perimeter of the mask. In one example, zones 56 and 58 haveequal pressures. For example, zones 56 and 58 have a pressure equal toabout 95% of the pressure in zone 50. In other examples, zones 56 and 58have a pressure equal to about 97.5%, about 92.5%, or about 90% of thepressure in zone 50.

Alternatively, zones 56 and 58 do not have equal pressures. For example,zone 56 has a pressure equal to about 95% of the pressure in zone 50 andzone 58 has a pressure equal to about 97.5% of the pressure in zone 50.In another example, zone 56 has a pressure equal to about 97.5% of thepressure in zone 50 and zone 58 has a pressure equal to about 95% of thepressure in zone 50. In other embodiments, zone 56 has a pressure equalto about 97.5%, about 95%, about 92.5%, or about 90% of the pressure inzone 50 and zone 58 has a pressure equal to about 97.5%, about 95%,about 92.5%, or about 90% of the pressure in zone 50.

FIG. 11 is a schematic diagram of a top view of an embodiment of theinvention. The facial mask 10 preferably includes an outward curvature44 between the supraorbital ridges 40 to prevent the facial mask 10 fromcontacting the glabella 18.

FIG. 12 is a schematic diagram of a side view of an embodiment of theinvention. As previously described, the facial mask 10 preferably doesnot contact the glabella 18, the root of the nose 20, the nose 22, thenostrils 24, the nasolabial folds (i.e., “smile lines” or “laugh lines”)26, the philtrum 28, or the chin boss 30 of the user. In a preferredembodiment, the facial mask 10 extends slightly under the chin of theuser, wherein a clearance of between about ⅛ inch to about ¼ inch isprovided. Alternatively, the clearance is between about ¼ inch and about½ inch. In another embodiment, the clearance is between about ½ inch andabout ¾ inch. In yet another embodiment, the clearance is between about¾ inch and about 1 inch. In other embodiments, the clearance is anymeasurement between about ¼ inch and about 1 inch. This clearanceprovides for chin mobility while wearing the facial mask 10, whichincreases the comfort to the user while wearing the facial mask 10.

Masks of the prior art do not extend across the forehead and beneath thechin, but rather are in contact with and supported by the glabella, rootof the nose, areas directly below the nose (e.g., the philtrum andnasolabial furrows), and/or the chin. Thus, the prior art teaches boththe more sensitive parts of the face supporting the mask (e.g., theglabella, philtrum, chin boss) and a smaller area of the face supportingthe mask. Advantageously, the present invention teaches a larger supportarea and less-sensitive parts of the face as support areas.

FIG. 13 is a schematic diagram of a side view of another embodiment ofthe invention. The facial mask 10 of FIG. 13 contacts a larger surfacearea of the face than the facial mask of FIG. 12. Specifically, thefacial mask 10 of FIG. 13 contacts a larger portion of the cheeks 14, alarger area under the mouth, and a portion of the jaw region 42.

FIG. 14 is a schematic diagram of a side view of yet another embodimentof the invention. The facial mask 10 of FIG. 14 contacts a largersurface area of the face than the facial mask of FIG. 13. Specifically,the facial mask 10 of FIG. 14 contacts a larger portion of the forehead12 (i.e., is closer to the hairline), a larger portion of the cheeks 14,and a larger portion of the j aw region 42.

FIG. 15 is a schematic diagram of a side view of an embodiment of theinvention shown in FIG. 9. In FIG. 15, the facial mask has two zones ofgraduated pressure. In one embodiment, zones 52 and 54 are graduatedpressure zones each having a pressure equal to less than 100% of thepressure in zone 50. In one example, zone 52 has a pressure equal toabout 97.5% of the pressure in zone 50 and zone 54 has a pressure equalto about 95% of the pressure in zone 50. In another example, zone 52 hasa pressure equal to about 95% of the pressure in zone 50 and zone 54 hasa pressure equal to about 90% of the pressure in zone 50.Advantageously, the graduated pressure zone distributes the load tominimize the pressure from the edge of the mask contacting the face ofthe user during use, as edge contact from the mask to the face of theuser sometimes creates create lines, wrinkles, or other undesiredcosmetic changes.

In a preferred embodiment, the facial mask includes ventilation holes toprovide additional comfort to the user. In one embodiment, theventilation holes are about 0.1 mm to about 2.5 mm in diameter. Inanother embodiment, the ventilation holes are convergent such that theentrance holes are greater in diameter than the exit holes. In oneembodiment, the ventilation holes have an entrance diameter of about 2.4mm and an exit diameter of about 0.8 mm. In a preferred embodiment, thefacial mask includes 40-50 ventilation holes.

FIG. 16 illustrates ventilation holes according to one embodiment of theinvention. In this embodiment, the ventilation holes 60 are concentricaround the airway passage 36. Although this embodiment is shown asconcentric around the airway passage, this configuration is also able tobe molded into other connective pieces between the device and mask(e.g., an elbow, a frame, a tube). Additionally, this embodiment isshown in a circular path concentric around the airway passage, but othershapes (e.g., triangular, rectangular) are possible.

The ventilation holes preferably are slanted to optimize air flow. Inone embodiment, the ventilation holes are angled about 30° to about 60°with respect to the surface. More preferably, the ventilation holes areangled about 45° with respect to the surface. In a preferred embodiment,the ventilation holes are unitarily formed into the mask through the 3Dprinting process.

FIG. 17 illustrates ventilation holes according to another embodiment ofthe invention. In this embodiment, the ventilation holes are positionedabove the airway passage 36. The ventilation holes preferably areslanted to move exhaled gases away from the user's face.

FIG. 18 is a schematic diagram of a top view of an embodiment of theinvention with ventilation holes 60.

FIG. 19 is a schematic diagram of a side view of an embodiment of theinvention with ventilation holes 60.

As previously described, the facial mask of the present inventionmatingly contacts at least 50% of the surface area of the face. The term“surface area” as used in this application means the total area of theoutside layer of a three-dimensional object (e.g., the face). Anarticle, “A geometric model of defensive peripersonal space” by authorsBufacchi et al. in the Journal of Neurophysiology, estimates the face asa half-ellipsoid with axes equal to 11.3 cm, 7.4 cm, and 9.8 cm. FIG. 20illustrates a half-ellipsoid with axes a, b, and c, and a height h of anellipsoid cap, which appears as a dotted region on the figure. Thesurface area of the half-ellipsoid is equal to 564.3 cm² (87.5 in²).Using values for h=9.8 cm (equivalent to 100% surface area of face),h=7.9 cm (equivalent to 80% surface area of face), h=5.02 cm (equivalentto 50% surface area of face), and h=2.05 cm (equivalent to 20% surfacearea of face), three-dimensional models were generated using SOLIDWORKS,a computer-aided design program.

FIG. 21 shows an angled perspective view of the half-ellipsoid with 20%of the surface area, 50% of the surface area, and 80% of the surfacearea of the half-ellipsoid labeled. As the eyes and mouth are the centerof the face, partial surface areas are determined from the periphery ofthe face toward the center of the face.

FIG. 22 shows a side perspective view of the half-ellipsoid with 20% ofthe surface area, 50% of the surface area, 80% of the surface area, and100% of the surface area of the half-ellipsoid labeled. Again, as theeyes and mouth are the center of the face, partial surface areas aredetermined from the periphery of the face toward the center of the face.

In one embodiment, eyeglasses are removably attachable to the face mask.Prior art documents describing attachment of eyeglasses to a maskinclude U.S. Pat. Nos. 6,776,485 and 8,113,200, and U.S. PublicationNos. 20050051171, 20170246415, and 20180064897, each of which isincorporated herein by reference in its entirety. In one embodiment, thefacial mask includes eyeglasses with lenses. In another embodiment, theeyeglasses are constructed from glass, plastic, high-index plastic,polycarbonate, a urethane-based pre-polymer (e.g., Trivex®), polyester,and/or silicone rubber. Alternatively, the lenses of the eyeglasses areconstructed from ballistic or bullet resistant glass. In anotherembodiment, the lenses include at least one coating (e.g.,anti-reflective coating, scratch-resistant coating). Eyeglasses includeglasses with corrective lenses, glasses with non-corrective lenses,sunglasses with lenses providing UV protection, goggles, andcombinations thereof.

In one embodiment, the mask includes at least one clip for attachingeyeglasses to the mask. The at least one clip is preferably located on aposition on the mask corresponding to a bridge of a nose. Additionally,or alternatively, the at least one clip is positioned on a left and aright side corresponding to a left temple and a right temple,respectively. In another embodiment, the mask includes at least onemagnet for attaching eyeglasses to the mask. The at least one magnet ispreferably located on a position on the mask corresponding to a bridgeof a nose, a left supraorbital ridge, a right supraorbital ridge, a leftside corresponding to a left temple, and/or a right side correspondingto a right temple. In one embodiment, the eyeglasses do not have arms.Alternatively, the eyeglasses have arms. In still another embodiment,the eyeglasses attach to one or more of the at least one strap.

FIG. 23A illustrates one embodiment of a facial mask 10 including facemask magnets 72 for attaching eyeglasses. The face mask magnets arepreferably adhered to, embedded in, or otherwise permanently affixed tothe face mask. FIG. 23B illustrates one embodiment of eyeglasses 70including eyeglasses magnets 74. The eyeglasses magnets are preferablyadhered to, embedded in, or otherwise permanently affixed to theeyeglasses. FIG. 23C illustrates the eyeglasses 70 of FIG. 23Bmagnetically attached to the facial mask 10 of FIG. 23A. In oneembodiment, the face mask magnets are positive and the eyeglassesmagnets are negative. In another embodiment, the face mask magnets arenegative and the eyeglasses magnets are positive.

FIG. 24 illustrates one embodiment of a facial mask 10 with a clip 76for attaching eyeglasses. The clip is permanently affixed to the facemask. The clip is preferably formed of plastic or metal.

FIGS. 25 and 26 illustrate embodiments of a face mask with a removableair filter 80. Rather than connecting to a sleep apnea device or anyother external system, the air filter is built into the mask and/or isinsertable into the mask, allowing the user to walk freely with it.Advantageously, compared to other filtered masks, the facial mask doesnot contact the eyes, nasal region, mouth, or chin boss of the user whenworn, allowing pressure to be distributed around less sensitive areas ofa wearer's face. In one embodiment, as shown in FIG. 25, the face maskextends around the eyes and at least partially covers the forehead. Inanother embodiment, as shown in FIG. 26, the face mask does not extendaround the eyes, instead extending over the nose and mouth and having anupper edge positioned beneath the eyes of a user's face. Having a facemask not extend over the eyes is advantageous in some situations, suchas when a user wants to use a pair of glasses that do not fit well overthe face mask. In one embodiment, the face mask includes a slit 85through which air filters are able to be added and/or removed from themask. In one embodiment, the air filter 80 is capable of filtering outpathogens, including but not limited to viruses, bacteria, and/oreukaryotic parasites. In one embodiment, the air filter 80 is capable offiltering out SARS-CoV-2 and influenza pathogens. In another embodiment,the air filter 80 is capable of filtering out non-biologicalparticulates, such as gas fumes from a work site. In one embodiment, asshown in FIG. 27, the face mask includes a plurality of flanges 90,operable to retain a removable air filter 95. In one embodiment, thebreathable surface area of the air filter is at least about 15 in². Inone embodiment, the removable air filter 95 is a disposable air filter.

In one embodiment, the facial mask includes at least one integral meshscreen. In one embodiment, the mesh screen region includes at least oneouter attachment mechanism, which is operable to hold filter paperagainst the mesh screen region facial mask. The filter paper is able tobe easily detached and replaced with new filter paper as needed. Inanother embodiment, the mesh screen includes an outer mesh screen and aninner mesh screen. Filter paper is able to be inserted between the outermesh screen and the inner mesh screen via a slit adjacent to the meshscreen region on the facial mask. In another embodiment, the facial maskincludes at least one hole. At least one air filter device is insertedinto the at least one hole such that the at least one air filter devicesealingly engages with the surrounding portion of the facial mask. Inone embodiment, the at least one air filter device is removed andreplaced by twisting the at least one air filter device. In anotherembodiment, the at least one air filter device automatically disengagesthe mask when sufficient pressure is applied to an outer surface of theat least one air filter device. In one embodiment, the at least one airfilter device includes at least one N95 filter.

In one embodiment, as shown in FIG. 28, the face mask includes abreathing portion 185 designed to fit over the nose and mouth of theindividual user. The breathing portion 185 includes at least one airfilter 180 for filtering out bacteria, viruses, and/or other pathogensand airborne pollutants. Having a larger breathing portion 185 to moreeasily fit over the mouth and the nose better allows an individual userto breathe through either their nose or their mouth. While this designchoice results in a larger, and often bulkier mask, it is oftenpreferred by some individuals. The face mask includes at least oneflange 165 for attachment to a strap to wrap around the head of theindividual user. The face mask includes eye holes 170. In oneembodiment, the eye holes 170 are able to be replace with eye protectionmaterials and/or lenses to correct for the eyesight of the individualuser. In another embodiment, the exterior surface of the breathingportion 185 includes at least one flange 175. The at least one flange175 includes an overhang. When at least one removable air filter ispressed against the breathing portion 185, the at least one flange 175deflects and subsequently engages with at least one groove on a sidewall of the at least one removable air filter or engages with at leastone surface of the at least one removable air filter, such that the atleast one removable air filter is held against the face mask. While FIG.28 shows an annular flange, it will be appreciated by one of ordinaryskill in the art that, in another embodiment, the at least one flangeincludes a plurality of individual flanges extending outwardly fromedges of the breathing portion 185.

In one embodiment, as shown in FIG. 29, the face mask includes at leastone sensor 102. In one embodiment, the at least one sensor 102 includesat least one temperature sensor. Because the at least one temperaturesensor is held in close proximity to a user's face by the face mask, itis able to determine the body temperature of a user. Detecting bodytemperature of a user assists in diagnosing any illness that a usercontracts, including but not limited to COVID-19 or influenza. Inanother embodiment, the at least one sensor 102 includes at least oneheart rate monitor, at least one heart rate variability monitor, atleast one movement sensor, and/or at least one moisture sensor. Theillustration in FIG. 29 shows at least one sensor 102 placed in contactwith a user's cheek, but the location of the at least one sensor is notlimited herein to only being in contact with a user's cheek. In anotherembodiment, the at least one sensor 102 is placed in contact with auser's forehead, chin, mouth, nose, and/or periorbital region.Additionally, the face mask includes a removable air filter 110.

FIG. 30 shows a face mask having an extended tube section 120. In oneembodiment, the extended tube section includes at least one radiativeemitter 122. The at least one radiative emitter 122 is operable to emitinfrared radiation (including, but not limited to, near-infraredradiation and far infrared radiation) and/or ultraviolet radiation(including, but not limited to, UVA, UVB, and UVC radiation). Theextended tube section 120 further includes at least one radiation shield124 in order to prevent infrared and/or ultraviolet radiation fromleaking from the extended tube section 120 and damaging a user's skin.In one embodiment, the entire outside surface of the extended tubesection 120 is also covered with radiation shielding material. Byincluding at least one radiative emitter 122, the face mask is furtherable to eliminate any pathogens that are able to pass through aremovable air filter 110, for example due to a damaged section of theremovable air filter 110 and/or at least one overly large pore in theremovable air filter 110.

FIGS. 29 and 30 show face masks having a removable air filter 110. FIG.31 illustrates an attachment mechanism for the removable air filter 110.The face mask includes an opening including an integrally formed grating118 or grid covering the opening. In one embodiment, the face maskincludes at least one groove 126 and at least one adjacent lip 128surrounding the opening of the face mask. The at least one groove 126 isoperable to engage with at least one clip section 116 of a removable airfilter 110, where the at least one clip section 116 extends outwardlyfrom an edge of at least one grating portion 112 of the removable airfilter 110. In one embodiment, at least one layer of filter material 114is disposed between the grating 118 of the face mask and the gratingportion 112 of the removable air filter 110.

FIG. 32 illustrates one embodiment of a removable air filter for a facemask. As shown in FIG. 32, the removable air filter 110 includes agrating portion 112 and at least one clip section 116 attached to anouter perimeter 115 of the grating portion 112. The at least one clipsection 116 includes at least one protrusion extending outwardly fromthe surface of the grating portion 112. An inner surface of the gratingportion 112 is defined as being on the side to which the at least oneprotrusion of the at least one clip section 116 extends and the sidethat will therefore be closer to the face mask when attached. An outsidesurface of the grating portion 112 is defined as being on the sideopposite that of the inner surface. The at least one clip section 116 isoperable to engage with the at least one groove 126 and the at least oneadjacent lip 128 of the face mask.

In one embodiment, when the at least one clip section 116 is engagedwith the at least one groove 126 and the at least one adjacent lip 128of the face mask, the grating portion 112 is configured to besubstantially in contact with a grating 118 of the face mask. Thegrating 118 of the face mask helps prevent portions of the face masksurrounding the opening from bending inward during use, which areotherwise capable of causing the removable air filter 110 to detach. Thegrating portion 112 of the removable air filter 110 similarly helpsprevent portions of the face mask surrounding the opening from bendingoutward during use. Furthermore, in one embodiment, at least one layerof filter material 114 is attached to the inner surface of the gratingportion 112, such that the at least one layer of filter material 114 istightly held between the grating portion 112 of the removable air filter110 and the grating 118 of the face mask when the removable air filter110 is attached. In another embodiment, the at least one layer of filtermaterial 114 is not attached to the removable air filter 110 before theremovable air filter 110 is attached to the face mask. Instead, the atleast one layer of filter material 114 is loosely disposed between thegrating 118 of the face mask and the grating portion 112 of theremovable air filter 110 and held in place via the contact between thegrating 118 and the grating portion 112.

In another embodiment, the removable air filter 110 does not include atleast one clip section 116. Instead, in one embodiment, the face maskincludes at least one flange, as shown in FIG. 28. When the removableair filter 110 is pressed onto the face mask, the at least one flangedeflects, allowing the removable air filter 110 to be closely fittedonto the face mask. In one embodiment, the removable air filter 110includes at least one groove. After the at least one flange deflects andthe removable air filter 110 is pressed against the face mask, the atleast one on flange is configured to bend back into position and engagewith the at least one groove. In another embodiment, the at least oneflange is configured to bend back into position such that an overhang oneach of the at least one flange is configured to engage with a surfaceof the removable air filter 110 oriented away from the face mask.

In one embodiment, the removable air filter 110 is attached to the facemask by at least one hinge. In a closed position, the grating portion112 and the grating 118 are substantially parallel and the gratingportion 112 and the grating 118 are substantially in contact. In an openposition, the grating portion 112 is rotated at an angle to the grating118 (e.g. the grating portion 112 is orthogonal to the grating 118) andthe grating portion 112 and the grating 118 are not substantially incontact. Therefore, when the removable air filter 110 is in an openposition, at least one layer of replacement filter material 114 is ableto be applied to the grating portion 112 and/or the grating 118 beforethe removable air filter 110 is moved to a closed position. In anotherembodiment, the removable air filter 110 and the face mask are entirelyseparate pieces and are not attached by a hinge.

In another embodiment, a flexible filter device is positioned over theopening and grating 118 of the face mask. A retaining device is affixedto the at least one groove 126 of the face mask and held in place by theat least one adjacent lip 128. The retaining device pinches the flexiblefilter device against the face mask such that the flexible filter deviceis removably affixed to the face mask. In one embodiment, the retainingdevice is an elastic band and/or a band with adjustable circumference,which is tightened when it is positioned around the at least one groove126.

In one embodiment, the edges of the face mask curve slightly inwardlytoward the device. The curved edges of the face mask help to create atighter seal for the face mask, better preventing pathogens fromentering the face mask and better preventing any substances appliedwithin the face mask from escaping. Furthermore, in embodiments whereinthe face mask does not extend over the eyes, the tighter seal helpsprevent warm breath from escaping the face mask and fogging up anyglasses that a user is wearing.

In one embodiment, the face mask includes at least one strap made of anelastic material that contacts the back of a user's head to hold theface mask in place. In another embodiment, the face mask includes atleast one strap made of an elastic material that contacts the back ofthe ears of the user to hold the face mask in place.

In one embodiment, the surface of the face mask is able to be printedwith a variety of design patterns. Allowing design patterns to beprinted on the outside surface of the face mask allows users to exercisecreativity and individuality in wearing the mask, which helps increasemask compliance during conditions such as a pandemic. In anotherembodiment, the face mask is substantially transparent. Having theoption to use a face mask that is transparent increases mask compliancefor many individuals. Because other individuals are able to both see auser's facial expressions and be able to better read their lips,communication with others while wearing the mask is substantiallyimproved.

Certain modifications and improvements will occur to those skilled inthe art upon a reading of the foregoing description. By way of example,the customized facial contour mask of the present invention is adaptedfor use with cosmetic treatments, in particular for time-release orextended-release of beneficial chemicals or topical applications to theface, especially to substantially the entire face surface (excluding theeyes, mouth, and nasal breathing passages). In alternative embodiments,the face mask is adapted for use by pilots, firemen, or firstresponders, for the military, for sports, or for extended-wear oxygenmasks or gas masks that provide increased comfort, wherein the masks arecustomized to the user's facial contours. The above-mentioned examplesare provided to serve the purpose of clarifying the aspects of theinvention and it will be apparent to one skilled in the art that they donot serve to limit the scope of the invention. All modifications andimprovements have been deleted herein for the sake of conciseness andreadability but are properly within the scope of the present invention.

The invention claimed is:
 1. A facial mask, comprising: a customized,contoured facial mask portion constructed and configured to matinglycover a corresponding contoured surface area of a face of an individualuser and match facial contours of the face of the individual user;wherein the facial mask includes strap attachments and at least onestrap for securing the customized, contoured facial mask portion to theface of the individual user during use; wherein the customized,contoured facial mask portion includes a contact portion for matinglycontacting the face of the individual user during use, wherein thecontact portion is formed based on a three-dimensional (3-D) scan of theface of the individual user, and the contact portion is adapted toconform to unique facial features and match the facial contours of theindividual user; wherein the contact portion is configured to notcontact a nose of the individual user during use; wherein the contactportion is configured to not contact a glabella of the individual userduring use; wherein the contact portion is configured to seal aroundeyes of the individual user during use; wherein the contact portion isadapted to substantially contact a forehead of the individual userduring use; wherein the facial mask is configured to cover the glabellaof the individual user during use; wherein the facial mask is configuredto not cover and not contact the eyes of the individual user during use;wherein the at least one strap is sized to extend around the individualuser's head and is for applying a pressure distributed across thecustomized, contoured facial mask portion; and wherein the facial maskincludes at least one replaceable air filter operable to filterbacterial and viral pathogens.
 2. The facial mask of claim 1, whereinthe pressure is distributed substantially uniformly across thecustomized, contoured facial mask portion that contacts the face of theindividual user.
 3. The facial mask of claim 1, wherein the customized,contoured facial mask portion is sized to matingly contact at least 50%of the surface area of the face of the individual user.
 4. The facialmask of claim 1, wherein the customized, contoured facial mask portionis sized to matingly contact at least 80% of the surface area of theface of the individual user.
 5. The facial mask of claim 1, wherein thecontact portion is configured to contact supraorbital ridges of theindividual user during use.
 6. The facial mask of claim 1, wherein thecontact portion is configured to not contact nasolabial furrows and/ornot contact a philtrum of the individual user during use.
 7. The facialmask of claim 1, wherein the customized, contoured facial mask portionis configured to substantially cover the nose of the individual userduring use.
 8. The facial mask of claim 1, wherein the contact portionis adapted to substantially contact cheeks of the individual user duringuse.
 9. The facial mask of claim 1, wherein eyeglasses are attachable tothe facial mask via at least one magnet and/or at least one clip. 10.The facial mask of claim 1, wherein a clearance of between about 3.175mm (⅛ inch) and about 6.35 mm (¼ inch) is provided below a chin of theindividual user during use.
 11. The facial mask of claim 1, wherein thestrap attachments consist of only two strap attachment points, whereinthe two strap attachment points are positioned on opposite sides of thefacial mask.
 12. The facial mask of claim 1, wherein the at least onestrap consists of a single axial strap.
 13. The facial mask of claim 1,wherein the facial mask includes a first material in contact with theface of the individual user and a second material to provide structuralsupport to the facial mask.
 14. The facial mask of claim 13, furtherincluding a material gradient transitioning from the first material tothe second material.
 15. The facial mask of claim 1, wherein the facialmask is comprised of at least one composition that is curable usingultraviolet (UV) light.
 16. The facial mask of claim 1, wherein thefacial mask includes at least one hole into which the at least onereplaceable air filter is inserted, and wherein, upon insertion, theleast one replaceable air filter sealingly engages with the facial mask.17. The facial mask of claim 1, wherein the at least one replaceable airfilter is operable to be removed from the facial mask by rotating the atleast one replaceable air filter and/or applying pressure to an outsidesurface of the at least one replaceable air filter.
 18. A facial mask,comprising: a customized, contoured facial mask portion constructed andconfigured to matingly cover a corresponding contoured surface area of aface of an individual user and match facial contours of the face of theindividual user; wherein the facial mask includes strap attachments andat least one strap for securing the customized, contoured facial maskportion to the face of the individual user during use; wherein thecustomized, contoured facial mask portion includes a contact portion formatingly contacting the face of the individual user during use, whereinthe contact portion is formed based on a three-dimensional (3-D) scan ofthe face of the individual user, and the contact portion is adapted toconform to unique facial features and match the facial contours of theindividual user; wherein the customized, contoured facial mask portionis adapted to extend below a chin of the individual user during use;wherein the contact portion is configured to not contact a chin boss ofthe individual user during use; wherein the contact portion isconfigured to not contact a nose of the individual user during use;wherein the contact portion is configured to not contact a glabella ofthe individual user during use; wherein the facial mask is configured tocover the glabella of the individual user during use; wherein the facialmask is configured to not cover and not contact the eyes of theindividual user during use; wherein the facial mask includes a firstmaterial in contact with the face of the individual user and a secondmaterial to provide structural support to the facial mask; and whereinthe facial mask includes at least one replaceable air filter operable tofilter bacterial and viral pathogens.
 19. The facial mask of claim 18,further including a material gradient transitioning from the firstmaterial to the second material.
 20. A facial mask, comprising: acustomized, contoured facial mask portion constructed and configured tomatingly cover a corresponding contoured surface area of a face of anindividual user and match facial contours of the face of the individualuser; wherein the facial mask includes strap attachments and at leastone strap for securing the customized, contoured facial mask portion tothe face of the individual user during use; wherein the customized,contoured facial mask portion includes a contact portion for matinglycontacting the face of the individual user during use, wherein thecontact portion is formed based on a three-dimensional (3-D) scan of theface of the individual user, and the contact portion is adapted toconform to unique facial features and match the facial contours of theindividual user; wherein the customized, contoured facial mask portionis adapted to extend below a chin of the individual user during use;wherein the contact portion is configured to not contact a chin boss ofthe individual user during use; wherein the contact portion isconfigured to not contact a nose of the individual user during use;wherein the contact portion is configured to seal around eyes of theindividual user during use; wherein the contact portion is adapted tosubstantially contact a forehead of the individual user during use;wherein the facial mask is configured to cover a glabella of theindividual user during use; wherein the facial mask is configured to notcover and not contact the eyes of the individual user during use;wherein the facial mask includes a first material in contact with theface of the individual user and a second material to provide structuralsupport to the facial mask; and wherein the facial mask includes atleast one replaceable air filter operable to filter bacterial and viralpathogens.